MAUDE Adverse Event Report: MALEM MEDICAL MALEM MEDICAL; ENURESIS OR INCONTINENCE ALARM

Model Number MO4S2

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 01/16/2017

Event Type  Injury  

Event Description

I am a doctor of internal medicine practicing in (b)(6).On a recent trip to the usa, i purchased several malem brand bedwetting alarms for my pts in (b)(6).These alarms are distributed to pts in my clinic.The alarms i purchased were brand new and purchased directly from an online website - (b)(6).The seller was (b)(6).I purchased 24 of the malem ultimate bedwetting alarms from the website - (b)(6).I have now distributed 14 of these to pts in (b)(6) and 8 of the parents have complained that within the first day - two weeks, the alarm has overheated to a point where the alarms back has become hot and partially melted.In each case, the child was suffered burns to his neck and chest area.The product appears to be extremely dangerous and can cause serious harm.I tested three malem alarms by putting a battery in them and two of these units have overheated and the back plastic has melted.

• Brand Name: MALEM MEDICAL
• Type of Device: ENURESIS OR INCONTINENCE ALARM
• Manufacturer (Section D): MALEM MEDICAL; nottingham ; UK
• MDR Report Key: 6278888
• MDR Text Key: 65917263
• Report Number: MW5067446
• Device Sequence Number: 1
• Product Code: KPN
• Reporter Country Code: PK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MO4S2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MALEM ULTIMATE BEDWETTING ALARM - MO4S2
• Patient Outcome(s): Hospitalization
• Patient Age: 6 YR
• Patient Weight: 31